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Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
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On-line Audio Seminar 281

FDA Compliant Handling of Out of Trend
Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides
for easy Implementation

Recorded, available with all reference material
at any time

FDA's guidance on OOS test results requires failure investigations and other
steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most
companies are familiar with and have procedures for OOS results, this is not the
case for OOT situations. The guide states: "Although the subject of this
document is OOS results, much of the guidance may be useful for examining
results that are out of trend". Managing OOT results also helps to avoid time
consuming OOS results. The industry is unsure how to interpret and implement the
FDA guidance.

Key Questions related to OOT and related failure investigations are:

What is an OOT results?

What is the difference between OOS and OOT result?

What does it mean: The guide 'may' also be useful for OOT
results?

'How much' and 'what' of the guidance is useful for OOT
results?

What exactly are the expectations of inspectors?

Can an OOT result trigger full investigations?

Who has overall responsibility for evaluating OOT results?

How to handle OOT results vs. OOS investigation?

Can we release a batch even if the OOT result can not be
resolved?

How should we document OOT investigations?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present the requirements of the new FDA OOS guidance and give
practical recommendations. After the seminar, an extensive list of
reference material like SOPs, worksheets, templates and examples
will help immediate and cost effective implementation. The SOPs and
checklist have been updated according to the FDA OOS guidance.

During the interactive presentation you learn about:

FDA regulations and guidelines

FDA's final Guidance for Industry: Investigating
Out-of-Specification (OOS) Test Results for Pharmaceutical
Production

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.